search
Back to results

Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries

Primary Purpose

Surgical Wound Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Water Exposure
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound Infection focused on measuring Post-operative management, Post-operative complications, Post-operative treatment, water, skin, Dermatologic Surgical Procedures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. subjects are capable of giving informed consent
  2. patients undergoing any surgical treatment of benign and malignant lesions by any physician in the Dermatology department consisting of:

    1. standard excisional surgery or Mohs micrographic surgery with immediate reconstruction
    2. reconstruction with primary linear closure or adjacent tissue transfer with one or two layers of suture

Exclusion Criteria:

  1. pregnancy
  2. age younger than 18 years
  3. will not be returning to the dermatology clinic in 7-14 days for suture removal
  4. documented or suspected infection of the site prior to surgery
  5. current treatment with systemic antibiotic therapy
  6. staged excisions
  7. delayed or staged reconstructions
  8. wounds repaired with skin or cartilage grafts
  9. management with secondary intention healing
  10. surgical site on or near a mucosal surface where standard dressings are not typically used (eyelid, vermilion, etc.)
  11. patients receiving prophylactic antibiotics
  12. patients deemed on a case-by-case basis by their surgeon to have a high risk of post-operative bleeding and requiring prolonged application of a pressure dressing
  13. history of skin sensitivity or reaction to white petrolatum

Sites / Locations

  • Department of Dermatology, Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Early Water Exposure

Standard Care

Arm Description

The Intervention group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure.

The Standard Care group will receive standard wound care instructions and verbal education by the staff to keep the dressing dry and intact for 48 hours.

Outcomes

Primary Outcome Measures

Post-operative wound infection

Secondary Outcome Measures

Incidence of post-operative bleeding complications
Scar appearance
Using a non-invasive scoring tool, participants and a blinded physician will rate the appearance of the scar 6 months after the surgery.
Skin Specific Quality of Life
Using a validated survey, information on the participants' quality of life will be assessed.

Full Information

First Posted
January 18, 2013
Last Updated
October 28, 2021
Sponsor
Milton S. Hershey Medical Center
Collaborators
American Society for Dermatologic Surgery
search

1. Study Identification

Unique Protocol Identification Number
NCT01773694
Brief Title
Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries
Official Title
Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
American Society for Dermatologic Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is likely to decrease the risk of infection and bleeding. However, this has never been formally studied. Patient's routines are likely disrupted when they are asked to avoid wetting the area. The investigators will perform a controlled study to determine if avoidance of post-operative wetting is necessary.
Detailed Description
Physicians commonly instruct their patients to keep a wound dry for 2 to 3 days following surgery. The rationale may be that sources of water like a shower, bathtub, or swimming pool may increase the risk of infection. There may also be a concern that changing a dressing in the early post-operative period will increase the risk of bleeding complications. However, patient's routines and quality of life are disrupted when they are asked to avoid bathing, exercise, and swimming. These issues have never been formally studied. This study will test the hypothesis of whether early post-operative wetting will have any influence on infection rates, bleeding complications, or the appearance of a surgical wound. Patients presenting to the Penn State Hershey dermatology clinic for the surgical removal of cancerous or non-cancerous skin lesions will be invited to participate. There will be no change to the standard surgical treatment. The dressing will be the same for all study participants. After surgery, study subjects who consent to participate will be randomized to receive one of two sets of post-operative instructions. One group will be directed to keep their initial post-operative dressing intact and dry for 48 hours. The second group will remove the dressing at 6 hours and wet the wound for 10 minutes in whatever manner they choose (shower, bath, pool, hot tub, etc.). After the initial dressing is removed (at 48 hours or 6 hours), both groups will perform identical post-operative care, consisting of cleansing the wound with soap and water followed by the application of petrolatum ointment and a dry dressing. All participants will follow-up 7 to 14 days after surgery or earlier if they are experiencing any problems. At this time, the site will be assessed for clinical evidence of infection and bleeding. If the former is present, a bacterial culture will be obtained to confirm a wound infection and patients will be treated with an antibiotic. Physicians performing the assessment will be blinded to the patient's status (early wetting group or not). All subjects will also complete a questionnaire inquiring how and when they wet their wounds after surgery as well as two questionnaires asking how their quality-of-life and function were affected. Participants will again follow-up at 6 months when a blinded investigator will assess the cosmetic appearance of the scars using an established scar rating tool. The data from this study will provide valuable evidence based guidance to surgeons in drafting wound care instructions for their patients. If the hypothesis proves correct, patients may be spared the inconvenience of post-operative water avoidance, diminishing the disruption to their lives caused by skin surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Post-operative management, Post-operative complications, Post-operative treatment, water, skin, Dermatologic Surgical Procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Water Exposure
Arm Type
Active Comparator
Arm Description
The Intervention group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
The Standard Care group will receive standard wound care instructions and verbal education by the staff to keep the dressing dry and intact for 48 hours.
Intervention Type
Behavioral
Intervention Name(s)
Early Water Exposure
Intervention Description
The Early Water Exposure (Intervention) group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure. On subsequent days, all participants, regardless of group assignment, will wash the wound daily with soap and water, reapply white petrolatum and a dry dressing.
Primary Outcome Measure Information:
Title
Post-operative wound infection
Time Frame
Post-operative day 7 to 14
Secondary Outcome Measure Information:
Title
Incidence of post-operative bleeding complications
Time Frame
Post-operative day 7 to 14
Title
Scar appearance
Description
Using a non-invasive scoring tool, participants and a blinded physician will rate the appearance of the scar 6 months after the surgery.
Time Frame
6 months post-operatively (+-5 days)
Title
Skin Specific Quality of Life
Description
Using a validated survey, information on the participants' quality of life will be assessed.
Time Frame
Post-operative days 7 to14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects are capable of giving informed consent patients undergoing any surgical treatment of benign and malignant lesions by any physician in the Dermatology department consisting of: standard excisional surgery or Mohs micrographic surgery with immediate reconstruction reconstruction with primary linear closure or adjacent tissue transfer with one or two layers of suture Exclusion Criteria: pregnancy age younger than 18 years will not be returning to the dermatology clinic in 7-14 days for suture removal documented or suspected infection of the site prior to surgery current treatment with systemic antibiotic therapy staged excisions delayed or staged reconstructions wounds repaired with skin or cartilage grafts management with secondary intention healing surgical site on or near a mucosal surface where standard dressings are not typically used (eyelid, vermilion, etc.) patients receiving prophylactic antibiotics patients deemed on a case-by-case basis by their surgeon to have a high risk of post-operative bleeding and requiring prolonged application of a pressure dressing history of skin sensitivity or reaction to white petrolatum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd V Cartee, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joslyn S Kirby, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20870635
Citation
Mudigonda T, Pearce DJ, Yentzer BA, Williford P, Feldman SR. The economic impact of non-melanoma skin cancer: a review. J Natl Compr Canc Netw. 2010 Aug;8(8):888-96. doi: 10.6004/jnccn.2010.0066.
Results Reference
background
PubMed Identifier
17276196
Citation
Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. doi: 10.1016/j.clindermatol.2006.09.007.
Results Reference
background
PubMed Identifier
17276197
Citation
Menke NB, Ward KR, Witten TM, Bonchev DG, Diegelmann RF. Impaired wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):19-25. doi: 10.1016/j.clindermatol.2006.12.005.
Results Reference
background
PubMed Identifier
14007593
Citation
WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. doi: 10.1038/193293a0. No abstract available.
Results Reference
background
Citation
Ratz, J.L. Textbook of dermatologic surgery, (Lippincott-Raven, Philadelphia, 1998).
Results Reference
background
Citation
Robinson, J.K. Surgery of the skin : procedural dermatology, (Elsevier Mosby, Philadelphia, 2005).
Results Reference
background
PubMed Identifier
21200270
Citation
Wolcott R, Dowd S. The role of biofilms: are we hitting the right target? Plast Reconstr Surg. 2011 Jan;127 Suppl 1:28S-35S. doi: 10.1097/PRS.0b013e3181fca244.
Results Reference
background
PubMed Identifier
8805732
Citation
Smack DP, Harrington AC, Dunn C, Howard RS, Szkutnik AJ, Krivda SJ, Caldwell JB, James WD. Infection and allergy incidence in ambulatory surgery patients using white petrolatum vs bacitracin ointment. A randomized controlled trial. JAMA. 1996 Sep 25;276(12):972-7.
Results Reference
background
PubMed Identifier
9371029
Citation
Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol. 1997 Nov;133(11):1433-40.
Results Reference
background
PubMed Identifier
22032650
Citation
Tsao S, Yao M, Tsao H, Henry FP, Zhao Y, Kochevar JJ, Redmond RW, Kochevar IE. Light-activated tissue bonding for excisional wound closure: a split-lesion clinical trial. Br J Dermatol. 2012 Mar;166(3):555-63. doi: 10.1111/j.1365-2133.2011.10710.x. Epub 2012 Jan 19.
Results Reference
background
PubMed Identifier
16079683
Citation
van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
Results Reference
background
PubMed Identifier
3450848
Citation
Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
Results Reference
background

Learn more about this trial

Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries

We'll reach out to this number within 24 hrs