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

October 28, 2021 updated by: Todd V Cartee, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

507

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Department of Dermatology, Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early Water Exposure
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.
Behavioral: Early Water Exposure

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.
No Intervention: Standard Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative wound infection
Time Frame: Post-operative day 7 to 14
Post-operative day 7 to 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-operative bleeding complications
Time Frame: Post-operative day 7 to 14
Post-operative day 7 to 14
Scar appearance
Time Frame: 6 months post-operatively (+-5 days)
Using a non-invasive scoring tool, participants and a blinded physician will rate the appearance of the scar 6 months after the surgery.
6 months post-operatively (+-5 days)
Skin Specific Quality of Life
Time Frame: Post-operative days 7 to14
Using a validated survey, information on the participants' quality of life will be assessed.
Post-operative days 7 to14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

American Society for Dermatologic Surgery

Investigators

  • Principal Investigator: Todd V Cartee, MD, Milton S. Hershey Medical Center
  • Principal Investigator: Joslyn S Kirby, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMC IRB 38335EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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